Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Japan Panel Green-Lights Pfizer’s Tukysa, Wider Labels for Tezspire, and More Drugs
A Japanese health ministry panel on January 29 recommended approvals for Pfizer’s new HER2-targeted cancer therapy tucatinib, marketed overseas under the brand name of Tukysa, together with a batch of label expansions for existing medicines. The Pharmaceutical Affairs Council’s Second…
To read the full story
Related Article
- Keytruda SC Heads to Japan Approval, Ipsen’s Ojemda for Conditional Nod
August 25, 2026
- Japan Approves AbbVie’s Aquipta, Novo’s IcoSema, Pfizer’s Tukysa, and More
February 20, 2026
- Japan Grants Orphan Tag to Bayer, Incyte Drugs, and 12 Others
February 17, 2026
- Japan Panel to Review Pfizer’s Cancer Med Tukysa on January 29
January 16, 2026
- Takeda Seeks Japan Nod for Vonvendi Use in Patients Under 18
June 11, 2025
- Keytruda Filed for Perioperative Use for Head and Neck Cancer in Japan
March 24, 2025
- Pfizer Japan Files NDA for Tucatinib for HER2 Breast Cancer
March 14, 2025
REGULATORY
- US Narrows Scope of Medicare MFN Model, Exempts Orphan-Only Drugs
October 2, 2026
- Japan to Draw Up Growth Strategy Action Plan by Year-End
October 2, 2026
- Chuikyo Backs Broader CEA Price Cuts This Year, Snubs Pharma Plea
October 1, 2026
- Repatha Optimal Use Guidelines to Be Simplified
October 1, 2026
- Label Revisions Ordered for Checkpoint Inhibitors over Gastritis, Esophagitis
September 30, 2026
The Wednesday TableShe had been on virtual calls since eight in the morning. The screen glowed. Her eyes burned. Plugged into Teams across time zones, she was digitally connected yet entirely isolated from the reality of Japan’s pharma market.She needed…
The development of Boehringer Ingelheim’s survodutide is gathering pace, putting the GLP-1/glucagon receptor agonist in contention to become the next…
Japan’s Central Social Insurance Medical Council (Chuikyo) on November 5 approved the reimbursement listing for a slate of new medicines,…
The Japanese government on March 7 announced new NHI prices to be applied in the FY2025 drug price revision, revealing…
The Japanese government approved a bill to amend the Pharmaceuticals and Medical Devices (PMD) Act at its Cabinet meeting on…
Japan’s health ministry doled out regulatory approvals for a throng of new medicines on December 27 including Eli Lilly’s obesity…
Japan’s all-important reimbursement policy panel on December 20 approved an outline of drug pricing reforms for FY2024, which enshrines a…